Ammonia
- Product NDC
- 70681-001
- 11-digit product format
- 706810001
- Labeler code
- 70681
- Product ID
- 70681-001_b2d6953c-71de-467f-ae45-54ce4f7a90db
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMMONIA N-13
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- The University of Texas Southwestern Medical Center
- Application
- ANDA209507
- Marketing category
- ANDA
- Marketing start
- 2020-05-01
- Substance
- AMMONIA N-13
- Active strength
- 37.5 mCi/mL
- Pharmacologic classes
- Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ammonia
- Brand name suffix
- N 13
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMMONIA N-13 | 37.5 mCi/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9OQO0E343Z |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70681-001-30 | AmmoniaN 13 | 30 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70681-001 | AMMONIA N 13 (AMMONIA N-13) INJECTION, SOLUTION [THE UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER] | 6 | Current NDC, Legacy NDC, 1 package rows | 20221202_e901d193-527d-4e39-8727-c152b56fb9e2.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70681-001-30 | 70681000130 | 30 mL in 1 VIAL, GLASS (70681-001-30) | 30 ml | 2020-05-01 | 0000-00-00 | No | No | Current |